Journal of Acupuncture Research

Korean Acupuncture & Moxibustion Medicine Society (대한침구의학회)
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Acupuncture Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Controlled Pilot Trial

  • Kim, Jung-Eun (Biomedical Research Institute, Pusan National University Hospital) ;
  • Kim, Sung-Phil (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Kim, Ae-Ran (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Park, Hyo-Ju (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Kwon, Ojin (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Jung, So-Young (Clinical Medicine Division, Korea Institute of Oriental Medicine) ;
  • Cho, Jung-Hyo (Department of Internal Korean Medicine, Dunsan Korean Medicine Hospital of Daejeon University) ;
  • Kim, Joo-Hee (Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Sangji University) ;
  • Choi, Sun-Mi (KM Standards Center, Korea Institute of Oriental Medicine)
  • Received : 2018.07.24
  • Accepted : 2018.08.03
  • Published : 2018.08.30
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Abstract

Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.

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References

  1. Koh K. Corticosteroid injection for adhesive capsulitis in primary care: a systematic review of randomised clinical trials. Singapore Med J 2016;57:646-657. https://doi.org/10.11622/smedj.2016146
  2. Manske RC, Prohaska D. Diagnosis and management of adhesive capsulitis. Curr Rev Musculoskelet Med 2008;1:180-189. https://doi.org/10.1007/s12178-008-9031-6
  3. Uppal HS, Evans JP, Smith C. Frozen shoulder: A systematic review of therapeutic options. World J Orthop 2015;6:263-268. https://doi.org/10.5312/wjo.v6.i2.263
  4. Son SK, Kim JS, Kim SW, Moon BH, Yoo SB, Lee CR. The domestic trends of traditional Korean medicine treatments on frozen shoulder. J Korea Chuna Med Spine Nerves 2014;9:55-65. [in Korean].
  5. Freedman J. An audit of 500 acupuncture patients in general practice. Acupunct Med 2002;20:30-34. https://doi.org/10.1136/aim.20.1.30
  6. Ewald A. Adhesive capsulitis: a review. Am Fam Physician 2011;83:417-422.
  7. Park TH, Oh CK, Park YL, Yang SB, Kim JH. A systematic review of randomized controlled trials on acupuncture for shoulder pain based on Jaded scale and revised STRICTA recommendations. Korean J Acupunct 2012;29:93-107. [in Korean].
  8. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 2005;4:287-291. https://doi.org/10.1002/pst.185
  9. Lee H, Hong KE, Kim YI, Yim YK, Ahn TW, Kang WC et al. A clinical trial of acupuncture treatment for frozen shoulder. J Korean Acupunct Moxib Soc 2006;23:165-177. [in Korean].
  10. Kim YI. Comparison study acupuncture treatment with acupuncture & moxibustion combined treatment for frozen shoulder patients. J Daejeon Oriental Med 2006;15:1-7. [in Korean].
  11. Park J, White A, Stevinson C, Ernst E, James M. Validating a new nonpenetrating sham acupuncture device: two randomised controlled trials. Acupunct Med 2002;20:168-174. https://doi.org/10.1136/aim.20.4.168
  12. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005;113:9-19. https://doi.org/10.1016/j.pain.2004.09.012
  13. Seo HD, Lee KW, Jung KS, Chung YJ. Reliability and validity of the Korean version of shoulder pain and disability index. J Spec Educ Rehab Sci 2012;51:319-336. [in Korean].
  14. Kim MH, Cho YS, Uhm WS, Kim S, Bae SC. Cross-cultural adaptation and validation of the Korean version of the EQ-5D in patients with rheumatic diseases. Qual Life Res 2005;14:1401-1406. https://doi.org/10.1007/s11136-004-5681-z
  15. Smyth CA. Evaluating sleep quality in older adults: the Pittsburgh sleep quality index can be used to detect sleep disturbances or deficits. Am J Nurs 2008;108:42-50.
  16. Farrar JT, Young JP Jr., LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149-158. https://doi.org/10.1016/S0304-3959(01)00349-9
  17. Lewis JA. Statistical principles for clinical trials (ICH E9): an introductory note on an international guideline. Stat Med 1999;18:1903-1942. https://doi.org/10.1002/(SICI)1097-0258(19990815)18:15<1903::AID-SIM188>3.0.CO;2-F
  18. Roe Y, Soberg HL, Bautz-Holter E, Ostensjo S. A systematic review of measures of shoulder pain and functioning using the International classification of functioning, disability and health (ICF). BMC Musculoskelet Disord 2013;14:73. https://doi.org/10.1186/1471-2474-14-73
  19. Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB et al. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain 2003;106:337-345. https://doi.org/10.1016/j.pain.2003.08.001
  20. Yuan QL, Wang P, Liu L, Sun F, Cai YS, Wu WT et al. Acupuncture for musculoskeletal pain: A meta-analysis and meta-regression of shamcontrolled randomized clinical trials. Sci Rep 2016;6:30675. https://doi.org/10.1038/srep30675
  21. Moore AR, Eccleston C, Derry S, Wiffen P, Bell RF, Straube S et al. "Evidence" in chronic pain--establishing best practice in the reporting of systematic reviews. Pain 2010;150:386-389. https://doi.org/10.1016/j.pain.2010.05.011
  22. Dyson-Hudson TA, Kadar P, LaFountaine M, Emmons R, Kirshblum SC, Tulsky D et al. Acupuncture for chronic shoulder pain in persons with spinal cord injury: a small-scale clinical trial. Arch Phys Med Rehabil 2007;88:1276-1283. https://doi.org/10.1016/j.apmr.2007.06.014
  23. Lathia AT, Jung SM, Chen LX. Efficacy of acupuncture as a treatment for chronic shoulder pain. J Altern Complement Med 2009;15:613-618. https://doi.org/10.1089/acm.2008.0272
  24. Angst F, Goldhahn J, Pap G, Mannion AF, Roach KE, Siebertz D et al. Crosscultural adaptation, reliability and validity of the German shoulder pain and disability index (SPADI). Rheumatology 2007;46:87-92. https://doi.org/10.1093/rheumatology/kel040
  25. Cho CH, Jung SW, Son ES, Hwang IS. Sleep status and quality of life in patients with frozen shoulder. J Korean Orthop Assoc 2012;47:205-210. [in Korean]. https://doi.org/10.4055/jkoa.2012.47.3.205
  26. Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials 2004;25:143-156. https://doi.org/10.1016/j.cct.2003.10.016
  27. Bang H. Random guess and wishful thinking are the best blinding scenarios. Contemp Clin Trials Commun 2016;3:117-121. https://doi.org/10.1016/j.conctc.2016.05.003
  28. Kolahi J, Bang H, Park J. Towards a proposal for assessment of blinding success in clinical trials: up-to-date review. Community Dent Oral Epidemiol 2009;37:477-484. https://doi.org/10.1111/j.1600-0528.2009.00494.x
  29. Linde K, Niemann K, Meissner K. Are sham acupuncture interventions more effective than (other) placebos? A re-analysis of data from the Cochrane review on placebo effects. Forsch Komplementmed 2010;17:259-264.